中药制剂吸湿性分析与防潮技术
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摘要
中药制剂由于其原料组分极易吸湿常发生吸湿过量的情况,含水量的提高易导致制剂稳定性减弱,同时使产品的成型难度增加。目前可用吸附理论、毛细管凝结理论、Fick扩散定理等阐述吸湿的基本原理,并采用多种评价指标判断吸湿程度,以此作为依据发展出多种中药制剂防潮技术。查阅近年来的相关文献,并结合具体实践总结目前普遍通行的吸湿原理、表征方法及可行的防潮技术,为中药制剂的防潮提供技术参考。
Excessive moisture absorption often occurs in Chinese material medica(CMM) preparations due to its raw material composition is easy to absorb moisture, the increases of water content easily weaken the stability of the preparations and increase the molding difficulty of the products at the same time. At present, the basic principle of moisture absorption can be explained by adsorption theory, theory of capillary condensation, and Fick diffusion theorem, combining a variety of evaluation indexes to judge the degree of moisture absorption, which can be as the basis for developing different moisture-proof technology of CMM preparations. The relevant literatures in recent years were reviewed in this paper, conbined with the widely recognized principle of moisture sorption, characterization method, and feasible moisture-proof technology, aiming to provide technical reference and implementation examples for the moisture-proof of CMM preparations.
Excessive moisture absorption often occurs in Chinese material medica(CMM) preparations due to its raw material composition is easy to absorb moisture, the increases of water content easily weaken the stability of the preparations and increase the molding difficulty of the products at the same time. At present, the basic principle of moisture absorption can be explained by adsorption theory, theory of capillary condensation, and Fick diffusion theorem, combining a variety of evaluation indexes to judge the degree of moisture absorption, which can be as the basis for developing different moisture-proof technology of CMM preparations. The relevant literatures in recent years were reviewed in this paper, conbined with the widely recognized principle of moisture sorption, characterization method, and feasible moisture-proof technology, aiming to provide technical reference and implementation examples for the moisture-proof of CMM preparations.
引文
[1]肖琼,沈平,朱莲华.中药固体制剂防潮技术与辅料应用的研究[J].中成药,2007,29(2):208-211.
[2]毕殿洲.药剂学[M].北京:人民卫生出版社,2000.
[3]熊耀坤,冯怡,肖飞艳,等.从热力学和动力学角度探讨中药吸湿机制[J].中华中医药杂志,2011,26(5):1189-1193.
[4]赵立杰,王优杰,冯怡,等.中药原料吸湿行为研究[J].中国新药杂志,2018,27(3):361-368.
[5]刘红淼.镇狂解郁胶囊制剂工艺及质量标准研究[D].石家庄:河北医科大学,2015.
[6]刘国平,赵立杰,冯怡,等.中药制剂原料吸湿动力学初步探讨[J].中国实验方剂学杂志,2014,20(6):15-19.
[7]中国药典[S].四部.2015.
[8]European Pharmacopoeia[S].Vol.1.2016.
[9]李盼.冠通胶囊制备工艺与质量标准研究[D].南宁:广西中医药大学,2016.
[10]岳国超,严霞,赵映波,等.湿法制粒工艺参数对颗粒成型性的影响[J].中南药学,2015,13(6):587-590.
[11]何倩灵.防潮辅料在中药固体制剂中的应用研究[D].成都:成都中医药大学,2011.
[12]周永全,李淞明,詹常森.中药浸膏粉吸湿性的评价方法[J].中成药,2017,39(5):1091-1093.
[13]冯怡.中药固体制剂技术理论与实践[M].北京:中国中医药出版社,2017.
[14]郎永英.益气固脱颗粒药学研究[D].南京:南京中医药大学,2014.
[15]孙政华,郭玫,邵晶,等.大孔吸附树脂纯化富集五脉绿绒蒿总生物碱[J].中成药,2016,38(1):77-83.
[16]高秀丽,王鹏娇,蒋蒨,等.中空纤维膜滤法对大红袍妇炎宁胶囊水提液除杂工艺的研究[J].华西药学杂志,2011,26(4):386-388.
[17]黄秀娟.膜分离技术在淀粉糖生产中的应用研究[D].广州:华南理工大学,2012.
[18]郭东艳,覃鸿恩,赵晓平,等.Zr O2无机陶瓷膜微滤技术精制健脑益智胶囊水提部分的研究[J].现代中医药,2014,34(5):69-72.
[19]梁雨虹,邓卓燕.不同辅料对中药全浸膏剂防潮效果探讨[J].北方药学,2016,13(2):190-191.
[20]周介南.用最短距离聚类法优选中药防潮辅料[J].山西医科大学学报,2012,43(11):822-824.
[21]常美月,石光,谭美月,等.不同辅料对人参提取物吸湿性影响研究[J].中国民族民间医药,2015,24(4):12-13.
[22]郭路红.扶正解毒漂浮颗粒剂的制备[D].广州:广东药科大学,2016.
[23]杨红,李小芳,尹帮龙,等.薄膜包衣技术在中药固体制剂防潮中的应用[J].中药与临床,2012,3(1):56-59.
[24]曾荣贵,蒋且英,廖正根,等.表面包覆改性技术改善中药浸膏粉体流动性及吸湿性研究[J].中国中药杂志,2016,41(12):2245-2249.
[25]易鹏.微囊化技术降低中药浸膏粉吸湿性机理及评价方法研究[D].成都:成都中医药大学,2013.
[26]李林,安富容,王琰.热熔挤出法增加布洛芬溶出度并改善磺丁基醚-β-环糊精吸湿性的研究[J].中国药房,2012,23(33):3117-3119.
[27]吴司琪,伍振峰,岳鹏飞,等.中药制粒工艺及其设备的研究概况[J].中国医药工业杂志,2016,47(3):341-346.
[28]朱则刚.药品包装材料及其市场观察[J].湖南包装,2014(3):8-14.
[2]毕殿洲.药剂学[M].北京:人民卫生出版社,2000.
[3]熊耀坤,冯怡,肖飞艳,等.从热力学和动力学角度探讨中药吸湿机制[J].中华中医药杂志,2011,26(5):1189-1193.
[4]赵立杰,王优杰,冯怡,等.中药原料吸湿行为研究[J].中国新药杂志,2018,27(3):361-368.
[5]刘红淼.镇狂解郁胶囊制剂工艺及质量标准研究[D].石家庄:河北医科大学,2015.
[6]刘国平,赵立杰,冯怡,等.中药制剂原料吸湿动力学初步探讨[J].中国实验方剂学杂志,2014,20(6):15-19.
[7]中国药典[S].四部.2015.
[8]European Pharmacopoeia[S].Vol.1.2016.
[9]李盼.冠通胶囊制备工艺与质量标准研究[D].南宁:广西中医药大学,2016.
[10]岳国超,严霞,赵映波,等.湿法制粒工艺参数对颗粒成型性的影响[J].中南药学,2015,13(6):587-590.
[11]何倩灵.防潮辅料在中药固体制剂中的应用研究[D].成都:成都中医药大学,2011.
[12]周永全,李淞明,詹常森.中药浸膏粉吸湿性的评价方法[J].中成药,2017,39(5):1091-1093.
[13]冯怡.中药固体制剂技术理论与实践[M].北京:中国中医药出版社,2017.
[14]郎永英.益气固脱颗粒药学研究[D].南京:南京中医药大学,2014.
[15]孙政华,郭玫,邵晶,等.大孔吸附树脂纯化富集五脉绿绒蒿总生物碱[J].中成药,2016,38(1):77-83.
[16]高秀丽,王鹏娇,蒋蒨,等.中空纤维膜滤法对大红袍妇炎宁胶囊水提液除杂工艺的研究[J].华西药学杂志,2011,26(4):386-388.
[17]黄秀娟.膜分离技术在淀粉糖生产中的应用研究[D].广州:华南理工大学,2012.
[18]郭东艳,覃鸿恩,赵晓平,等.Zr O2无机陶瓷膜微滤技术精制健脑益智胶囊水提部分的研究[J].现代中医药,2014,34(5):69-72.
[19]梁雨虹,邓卓燕.不同辅料对中药全浸膏剂防潮效果探讨[J].北方药学,2016,13(2):190-191.
[20]周介南.用最短距离聚类法优选中药防潮辅料[J].山西医科大学学报,2012,43(11):822-824.
[21]常美月,石光,谭美月,等.不同辅料对人参提取物吸湿性影响研究[J].中国民族民间医药,2015,24(4):12-13.
[22]郭路红.扶正解毒漂浮颗粒剂的制备[D].广州:广东药科大学,2016.
[23]杨红,李小芳,尹帮龙,等.薄膜包衣技术在中药固体制剂防潮中的应用[J].中药与临床,2012,3(1):56-59.
[24]曾荣贵,蒋且英,廖正根,等.表面包覆改性技术改善中药浸膏粉体流动性及吸湿性研究[J].中国中药杂志,2016,41(12):2245-2249.
[25]易鹏.微囊化技术降低中药浸膏粉吸湿性机理及评价方法研究[D].成都:成都中医药大学,2013.
[26]李林,安富容,王琰.热熔挤出法增加布洛芬溶出度并改善磺丁基醚-β-环糊精吸湿性的研究[J].中国药房,2012,23(33):3117-3119.
[27]吴司琪,伍振峰,岳鹏飞,等.中药制粒工艺及其设备的研究概况[J].中国医药工业杂志,2016,47(3):341-346.
[28]朱则刚.药品包装材料及其市场观察[J].湖南包装,2014(3):8-14.